dynaMX(TM) Nitinol Compression Screw
K-Number: K160427 · 2016-06-03
ApplicantMx Orthopedics, Corp.
Decision Date2016-06-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
dynaMX(TM) Nitinol Compression Screw is a medical device manufactured by Mx Orthopedics, Corp.. It received FDA 510(k) clearance on 2016-06-03 under approval number K160427. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the dynaMX(TM) Nitinol Compression Screw?
dynaMX(TM) Nitinol Compression Screw is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by Mx Orthopedics, Corp.. The 510(k) number is K160427.
When was dynaMX(TM) Nitinol Compression Screw approved by the FDA?
dynaMX(TM) Nitinol Compression Screw received FDA 510(k) clearance on 2016-06-03, under approval number K160427.
What company makes dynaMX(TM) Nitinol Compression Screw?
dynaMX(TM) Nitinol Compression Screw is manufactured by Mx Orthopedics, Corp..
What is the FDA product code for dynaMX(TM) Nitinol Compression Screw?
The FDA product code for dynaMX(TM) Nitinol Compression Screw is HWC. This falls under the Cardiovascular category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.